NIET-KLEINCELLIG LONGCARCINOOM (NSCLC)
Conditions
Interventions
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study: - Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study;- First dose of study treatment in the extension study will be received within the treatment interruption period allowed by the parent study;- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator;- Able to comply with the extension study, in the investigator's judgment;- Will comply with contraception criteria detailed in the protocol;- Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential.;2. Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq(R)) outside this extension study and continue safety and survival follow-up only in the extension study: - Discontinuation of atezolizumab-based therapy in parent study and in survival follow-up at the time of parent study closure. or Eligible for continuing or crossing over to atezolizumab-based therapy as per the parent protocol and have access to commercially available atezolizumab (Tecentriq) outside this extension study at the time of the parent-study closure.
Exclusion criteria
Exclusion criteria: 1. Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study: - Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study.;- Study treatment is commercially marketed in the patient*s country for the patient specific disease and is accessible to the patient.;- Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period allowed in the parent study. If the interruption period is beyond the period allowed by the parent study, the acceptable length of interruption will depend on an agreement between the investigator and the Medical Monitor of the extension study.;- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study.;- Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study (if applicable).;- Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information;- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to provide continued access to atezolizumab based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent study closure. There is no primary efficacy endpoint in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint is overall survival (OS). OS is defined as the time from randomization date or initiation of study treatment date (as applicable) in the parent study to death due to any cause date. Patients who are alive at the data cutoff date will be censored at the date the patient was last known to be alive. The secondary safety objective is to evaluate the safety following exposure to atezolizumab monotherapy or atezolizumab administered with combined agent(s). The corresponding endpoints are the incidence and severity of serious adverse events and adverse events of special interest, with severity determined according to NCI CTCAE, v4.0. | — |
Countries
The Netherlands
Outcome results
None listed